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TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB

NCT00664313 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-07-06

Study results available
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Summary

This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB).

Conditions

  • Multi-drug Resistant Tuberculosis
  • Extensively Drug Resistant Tuberculosis

Interventions

DRUG

Linezolid

600 mg po daily for 112 doses (16 weeks)

DRUG

Placebo

Placebo given daily for 112 doses (16 weeks)

Sponsors & Collaborators

Principal Investigators

  • Jussi Saukkonen, MD · Boston University

  • Waffa El-Sadr, MD · Columbia University

  • Nesri Padayachin, MBChB · University of Kwa-Zulu Natal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664313 on ClinicalTrials.gov